Clincosm LogoSign in Get a demo

751: Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study

Sponsor
Hoya Surgical Optics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01544777
Collaborator
(none)
42
Enrollment
1
Location
3
Arms
6
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

Condition or Disease Intervention/Treatment Phase
  • Device: Study IOL
  • Device: Hoya iSert 751
  • Device: Negatively aspheric IOL
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Both Eyes

Model 751 IOL implanted in both eyes.

Device: Study IOL
Aspheric IOL for correction of aphakia
Other Names:
  • Hoya iSert 751 IOL

    		•
    Experimental: Single eye

    Model 751 IOL in one eye

    Device: Hoya iSert 751
    Model 751 in one eye, standard IOL in other eye
    Other Names:
  • Hoya iSert Model 751

    		•
    Active Comparator: Control

    Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

    Device: Negatively aspheric IOL
    Negatively aspheric IOL in both eyes
    Other Names:
  • Hoya iSert model 251 or equivalent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near [Up to 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Senile cataract

    • Patient identified as a candidate for cataract surgery and IOL implantation

    • Willing to sign informed consent document approved by the Ethical Committee

    • Willing to complete all required tests and exams per this protocol

    Exclusion Criteria:

    • Amblyopia

    • History or evidence of any ocular disease that may affect visual acuity

    • Previous ocular surgery, including refraction surgery

    • Ocular anomalies (e.g. microphthalmos, kerataconous)

    • Subjects with greater than 1.0 D of corneal astigmatism

    • Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sir Charles Gairdner Hospital Nedlands Western Australia Australia 6009

    Sponsors and Collaborators

    • Hoya Surgical Optics, Inc.

    Investigators

    • Principal Investigator: Graham Barrett, MD, Sir Charles Gairdner Hospital, Nedlans WA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoya Surgical Optics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01544777
    Other Study ID Numbers:
    • DOF-1
    First Posted:
    Mar 6, 2012
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Aug 1, 2012
    Keywords provided by Hoya Surgical Optics, Inc.
    Aphakia
    Cataract
    Additional relevant MeSH terms:
    Cataract
    Aphakia

    Study Results

    No Results Posted as of Mar 25, 2015